Safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening, based on a dossier submitted for the modification of the terms of authorisation of the additive. The product is authorised in the European Union for chickens for fattening at the maximum content of 1,000 mg/kg complete feedingstuffs. The applicant proposed the introduction of an additional manufacturing process, which introduces an impurity (dimethylamino-ethanol (DMAE)) in the additive at concentrations up to 0.09%. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered that the proposed modification would not substantially affect the previous assessment as related to the safety of the environment and the efficacy of the product. Since the safety of the active substance was established, the current assessment has dealt with the impurity DMAE. Considering the toxicological profile of DMAE, the estimated intake by the target animal and consumers, and making use of the Threshold of Toxicological Concern (TTC) approach, the Panel concluded that Taminizer D, manufactured by the DMAE route, is safe for both chickens for fattening and consumers, up to the maximum level of 1,000 mg/kg feed. The FEEDAP Panel extends its conclusions about Taminizer D produced by the original method to cover also Taminizer D produced by the new DMAE method. There is minimal risk to users from dust produced as a result of normal handling of the additive. Taminizer D is not irritant to skin but may be irritant to eyes; it is regarded as a potential skin sensitiser. The FEEDAP Panel recommended to set a specification for the DMAE content in the additive

Safety and efficacy of Kelforce \uae (l-glutamic acid, N,N-diacetic acid, tetrasodium salt (GLDA-Na 4 )) as a feed additive for chickens for fattening

l-Glutamic acid, N,N-diacetic acid, tetrasodium salt (GLDA-Na 4 ) (Kelforce \uae ) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce \uae is intended to be marketed as a liquid and solid formulation, containing 65 47% and 65 30% of GLDA-Na 4 , respectively. Kelforce \uae is safe for chickens for fattening at the maximum level of 1,000 mg GLDA-Na 4 /kg complete feed. Based on the toxicological profile of GLDA-Na 4 and the consumer exposure to GLDA-Na 4 and to nitrilotriacetic acid trisodium salt (NTA-Na 3 ; an impurity of the additive), the use of Kelforce \uae at the maximum proposed level in feed of chickens for fattening is of no concern for consumer safety. Due to its low inhalation toxicity, the exposure to GLDA-Na 4 is unlikely to pose a risk by inhalation. However, owing to the high-dusting potential of the solid formulation, a risk from such high level of dust, even if toxicologically inert, cannot be excluded. Kelforce \uae is not a skin/eye irritant or skin sensitiser. No risks for the terrestrial compartment were identified at the maximum use level of the additive. Risks for the aquatic compartment cannot be excluded based on the secondary effect of the additive on green algae. In the absence of data, the Panel cannot conclude on the safety for the sediment compartment or the possible ground water contamination. The risk of bioaccumulation and secondary poisoning caused by the additive is considered very low. Owing to the inconsistent and conflicting results from the studies assessed, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the efficacy of the additive. The Panel made a recommendation regarding the levels of formaldehyde and cyanide in the active substance

Safety of the feed additive consisting of manganese chelates of lysine and glutamic acid for all animal species (Zinpro Animal Nutrition)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety for target animals of manganese chelates of lysine and glutamic acid (Manganese-LG) as a nutritional feed additive for all animal species. The European Commission request followed an opinion of the FEEDAP Panel published in 2020; in that opinion, the FEEDAP Panel could conclude on the safety of the additive for chickens for fattening, but not for the rest of the target animals. The applicant submitted additional information to allow the FEEDAP Panel to complete its assessment; these additional data, comprising two tolerance studies (one with chickens for fattening and one with laying hens), were the subject of this opinion. The tolerance study in laying hens was not considered for the assessment since the housing conditions of the animals were not appropriate according to the relevant EU provisions. The results of the tolerance study in chickens for fattening showed that Manganese-LG at the highest level tested – 800 mg Mn/kg feed – is safe for these target animals. The FEEDAP Panel also considered a previous tolerance study in chickens for fattening. Taking all the evidence together the Panel concluded that Manganese-LG is safe for chickens for fattening at 150 mg Mn/kg feed, with a margin of safety of 5.5. This conclusion can be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total manganese in feed are not exceeded

Safety and efficacy of fumonisin esterase from Komagataella phaffii DSM 32159 as a technological feed additive for pigs and poultry

Fumonisin esterase produced from a genetically modified strain of Komagataella phaffi is intended to degrade fumonisin mycotoxins contaminants in feeds for pigs and poultry. The production strain and its recombinant genes are not present in the final product. The applicant selected 300 U/kg feed to represent a likely upper limit. This concentration showed to be safe for piglets, chickens and turkeys for fattening and laying hens; the additive is thus safe for those categories. This conclusion is extended to all pigs, chickens reared for laying and turkeys reared for breeding and extrapolated to all other poultry species for growing and laying and to minor porcine species. No evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity from a repeated-dose oral toxicity study; the residue assessment did not identify any concern. The use of the additive is, thus, considered safe for consumers. The additive is not toxic by inhalation and the respiratory exposure is likely to be low; however, a risk of sensitisation via the respiratory route cannot be excluded. The additive is non-irritant to skin and eyes and is not considered a dermal sensitiser. No risks for the environment are expected following the use of the additive in feeds under the proposed condition of use. The additive has the capacity to degrade fumonisin contaminants in feed of marketable quality when used at the minimum recommended dose of 10 U/kg complete feed, as shown in studies with chickens for fattening, laying hens and weaned piglets. Since the mode of action of the additive can be reasonably assumed to be the same in animal species for which the application is made, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers the additive efficacious for all poultry and all pigs

Safety and efficacy of copper chelates of lysine and glutamic acid as a feed additive for all animal species

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelates of lysine and glutamic acid (Copper-LG) as a nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that, owing to safety considerations, Copper-LG should not be used in water for drinking. Copper-LG is safe for chickens for fattening; this conclusion can be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total copper in feed are not exceeded. No increases in the copper content of animal tissues/products are expected from the use of Copper-LG in animal nutrition. There is no indication that the toxicity of Copper-LG is essentially different from that of inorganic divalent copper. The use of Copper-LG in animal nutrition is of no concern for consumer safety provided that the maximum authorised total copper in feed is respected. Owing to the copper and nickel content of Copper-LG, the handling of the additive, poses a risk to users by inhalation. The additive is considered as a skin and respiratory sensitiser; it is corrosive to the eye while it is non-irritant to skin. The additive is intended to be a substitute for other authorised copper additives and will not further increase the environmental burden of copper; therefore, the FEEDAP Panel considers that the use of the additive in animal nutrition would not pose an additional risk for the environment. Copper-LG is a bioavailable source of copper, comparable to the standard inorganic copper source, and therefore, the additive is efficacious in meeting the birds copper requirements; this conclusion can be extrapolated to all animal species/categories. The FEEDAP Panel posed a recommendation concerning the description of the additive

Safety and efficacy of benzoic acid for pigs and poultry

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked by the European Commission to deliver a scientific opinion on the safety and efficacy of benzoic acid as feed flavouring for piglets (suckling, weaned), pigs for fattening, sows (for reproduction, in order to have benefit in piglets), minor porcine species, chickens (for fattening, reared for laying), hens (laying, breeding), turkeys (for fattening, for breeding purposes, reared for breeding) and minor poultry species. Benzoic acid is safe for weaned piglets at 2,500 mg/kg feed, and for laying hens, turkeys and chickens for fattening at 500 mg/kg feed; no conclusions could be drawn for suckling piglets and sows. The conclusions on weaned piglets can be extended to pigs for fattening and extrapolated to growing minor porcine species. The conclusions on chickens/turkeys for fattening can be extended to chickens reared for laying and turkeys reared for breeding and extrapolated to minor poultry species up to the point of lay. In the absence of safety margin in laying hens, no conclusions can be reached for minor poultry species for laying/breeding. The use of the additive is not expected to pose a risk to consumer, considering that the additive is rapidly metabolised with very low deposition, if any, in edible tissues of pigs and poultry and that foods of animal origin provide a very minor contribution, if any, to the overall dietary intake of benzoic acid. Owing to the unlikelihood of exposure, no risk to users upon inhalation of the additive is expected; the additive is not a skin sensitiser, but is a skin/ eye irritant. The proposed use of the additive does not pose environmental risks. Benzoic acid is authorised as food flavouring and its function in feed is essentially the same; no further demonstration of efficacy is necessary

Safety and efficacy of Biomin \uae DC-C as a zootechnical feed additive for weaned piglets

The additive (trade name Biomin \uae DC-C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l-menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were exposed to feed containing up to an intended 1,250 mg additive/kg complete feed showed that additive is safe for piglets at the maximum recommended level with at least a sixfold margin of safety. The active components of the additive are not genotoxic and from the available residue study, based on the detection of five marker compounds, no measurable exposure of the consumers is foreseen; consequently, the use of the additive is considered safe for consumers of animal products. The FEEDAP Panel considered that exposure to users by inhalation is unlikely; in the absence of data, the Panel cannot conclude on the effects of Biomin \uae DC-C on skin and eyes. The use of the additive in animal production is not expected to pose a risk for the terrestrial or aquatic environments. Based on the results of three efficacy studies in which positive benefits were seen, the additive has a potential to improve the growth performance of weaned piglets at a minimum application rate of 75 mg/kg complete feed

Safety and efficacy of Biomin ® DC-C as a zootechnical feed additive for weaned piglets

The additive (trade name Biomin \uae DC-C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l-menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were exposed to feed containing up to an intended 1,250 mg additive/kg complete feed showed that additive is safe for piglets at the maximum recommended level with at least a sixfold margin of safety. The active components of the additive are not genotoxic and from the available residue study, based on the detection of five marker compounds, no measurable exposure of the consumers is foreseen; consequently, the use of the additive is considered safe for consumers of animal products. The FEEDAP Panel considered that exposure to users by inhalation is unlikely; in the absence of data, the Panel cannot conclude on the effects of Biomin \uae DC-C on skin and eyes. The use of the additive in animal production is not expected to pose a risk for the terrestrial or aquatic environments. Based on the results of three efficacy studies in which positive benefits were seen, the additive has a potential to improve the growth performance of weaned piglets at a minimum application rate of 75 mg/kg complete feed

Safety and efficacy of Biomin\uae DC-P as a zootechnical feed additive for chickens for fattening, chickens reared for laying and minor avian species to the point of lay

The additive (trade name Biomin\uaeDC-P) is a blend of five individual compounds (carvacrol, thymol, d-carvone, methyl salicylate and l-menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for various poultry species at a minimum concentration of 65 mg/kg complete feed and a recommended maximum level of 105 mg/kg complete feed. The results of a tolerance study show that Biomin\uae DC-P is safe for chickens for fattening at the maximum recommended application rate of 105 mg/kg complete feed; this conclusion is extended to include chickens reared for laying and extrapolated to minor poultry species The active components of a previously evaluated additive (Biomin\uaeDC-C) were shown to be not genotoxic; owing to the similarity on composition, this conclusion can be also applied to Biomin\uaeDC-P. Notwithstanding the uncertainties identified in the residue study, after applying a worst-case scenario to calculate potential exposure of consumers to menthol and carvone, and since that the components of the additive are considered safe for their use as food and feed flavourings, the FEEDAP Panel concludes that the use of the additive in animal nutrition is considered safe for consumers. The FEEDAP Panel considered that exposure of users by inhalation is unlikely, but cannot conclude on the effects of Biomin\uaeDC-P on skin and eyes. The use of Biomin\uaeDC-P is not expected to pose a risk for the environment. Biomin\uaeDC-P has a potential to increase the growth performance of chickens for fattening when incorporated into feed at a minimum application rate of 65 mg/kg complete feed; the conclusion can be extended to chickens reared for laying and extrapolated to minor poultry species reared up to the point of lay

Safety and efficacy of VevoVitall\uae (benzoic acid) as feed additive for pigs for fattening

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of VevoVitall\uae (benzoic acid) as a zootechnical feed additive for pigs for fattening. The additive is currently authorised for pigs for fattening with the effect of \u2018urinary pH decrease\u2019 at the minimum and maximum use of 5,000 and 10,000 mg/kg complete feed, respectively. The current application intends to support the use of the additive with the specific effect of \u2018improvement of performance parameters\u2019 at the minimum dose of 3,000 mg additive/kg complete feed, and keeping the same other conditions as for the use already authorised. The FEEDAP Panel assessed already the safety of the product when used in pigs for fattening in 2007 and 2017. The Panel confirms its former assessments that VevoVitall\uae used as a feed additive in pigs for fattening at the maximum level of 10,000 mg/kg is considered as safe for pigs for fattening, consumers of food derived from pigs fed the additive and the environment. VevoVitall\uae does not pose a risk by inhalation to users and is not a skin sensitiser but is a skin irritant and a severe eye irritant. Based on the results of three efficacy studies, the FEEDAP Panel concluded that VevoVitall\uae has the potential to increase the performance in pigs for fattening at the level of 3,000 mg/kg complete feed